Introduction
Methods
Literature search strategy
Inclusion and exclusion criteria
Population | Adult patients with acute respiratory distress syndrome (ARDS) |
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Intervention | VV-ECMO |
Comparison | Comparison with those treated with mechanical ventilation |
Outcome | Health-related quality of life |
Study design | Prospective and retrospective cohort studies Randomized controlled trial |
Study selection
Assessment of risk of bias in included studies
Results
Study selection
Characteristics of the studies
Parameter | First author and origin of the study | |||||||
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Galazzi et al. [39] Italy | Grasselli et al. [40] Italy | Hodgson et al. [41] Australia | O’Brien et al. [42] Ireland | Peek et al. [43] UK | Sanfilippo et al. [44] Italy | Sylvestre et al. [45] France | Wang et al. [46] China | |
Study design | Quantitative retrospective observational study (cohort) | Quantitative prospective observational study (cohort) | Quantitative retrospective observational study (cohort) | Quantitative retrospective observational study (cohort) | Quantitative randomized controlled trial (RCT) | Quantitative prospective observational study (cohort) | Quantitative retrospective observational study (cohort) | Quantitative prospective observational study (cohort) |
Total population (N)—HRQoL sample size | ||||||||
VV-ECMO | 26–17 | 26–18 | 18–15 | 19–13 | 57–52 | 43–33 | 49–22 | 27–24 |
MV | N/A | 31–19 | N/A | N/A | 46–32 | N/A | 36–18 | 63–48 |
Sex (M) (%) | ||||||||
VV-ECMO | 12 (70%) | 24 (70%) | 10 (48%) | 7 (54%) | 51 (57%) | 24 (73%) | 12 (55%) | 18 (75%) |
MV | N/A | 31 (62%) | N/A | N/A | 53 (59%) | N/A | 11 (61%) | 33 (69%) |
Age (years) | ||||||||
VV-ECMO | 49 (38–55) | 54 (41–63) | 36.3 ± 12.1 | 44 ± 11 | 39.9 ± 13.4 | 45.0 ± 9.8 | 41 (32–56) | 38.0 ± 15.1 |
MV | N/A | 54 (45–70) | N/A | N/A | 40.4 ± 13.4 | N/A | 51 (43–63) | 44.3 ± 15.6 |
VV-ECMO duration (days) | ||||||||
VV-ECMO | 19 (15–33) | 9 (6–13) | 10.6 (3.6–15.8) | 15 (11–19) | 9 (6–16) | 10 (7–15) | 12 (8–19) | 6.0 ± 2.3 |
MV | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
MV duration (days) | ||||||||
VV-ECMO | 36 (12–74) | 21 (11–35) | 15.3 (12.0–23.2) | 3 (2–20) of pre-ECMO | 10 (4.8–22.8) | 2 (1–4) days pre-ECMO and 9 (4–16) days post-ECMO | 36 (28–64) | 10.0 (6.0–16.3) |
MV | N/A | 8 (5–21) | N/A | N/A | 11 (4.0–20.3) | N/A | 29 (21–46) | 9.0 (6.0–13.0) |
ICU stay (days) | ||||||||
VV-ECMO | 37 (20–79) | 24 (15–36) | 20.7 (14.9–28.6) | 31 (25–74) | 24 (13.0–40.5) | 2 (1–7) but only pre-ECMO | 46 (34–71) | 13.0 (9.8–22.3) |
MV | N/A | 11 (5–25) | N/A | N/A | 13 (11–16) | N/A | 35 (24–47) | 11.0 (8.0–18.0) |
Hospital stay (days) | ||||||||
VV-EMCO | N/A | 33 (19–48) | 28.4 (18.5–37.7) | N/A | 35 (15.6–74.0) | 4 (2–8) but only pre-ECMO | 61 (45–99) | 25.5 (16.5–31.3) |
MV | N/A | 23 (12–45) | N/A | N/A | 17 (4.8–45.3) | N/A | 55 (43–90) | 26.0 (15.0–56.3) |
Discharge destination | ||||||||
VV-ECMO | N/A | 92% to home; 8% to other hospital | 44% to home; 50% to other hospital; 6% to rehabilitation facility | 47% to referral hospital; 23% to a rehabilitation center; 31% to home | N/A | N/A | N/A | 92% to home; 8% to other hospital |
MV | N/A | 90% to home; 10% to other | N/A | N/A | N/A | N/A | N/A | 90% to home; 10% to other |
Follow-up time (months) | ||||||||
VV-ECMO | 17 (14–25) | 12 | 8.4 (6–16) | 36 (14–39) | 6 | 2.7 (2–5) years | 20 (17–22) | 12.7 ± 5.8 |
MV | N/A | 12 | N/A | N/A | 6 | N/A | 22 (18–23) | 14.8 ± 6.5 |
HRQoL assessment tool(s) | EQ-5D | SF-36, SGRQ, IES-R | SF-36, EQ-5D | SF-36, HADS, IES-R | SF-36, EQ-5D, SGRQ, HADS, mini-mental examination, and specific questions about sleep | SF-36, HADS, CES-D, IES-R | SF-36, BDI-IA, BAI, IES | SF-36, EQ-5D |
Reported HRQoL outcomes | Perceived QoL = 75%; 60% showed good outcomes physically and psychosocially; 71% returned to their normal working activities | One-year survival was similar between VV-ECMO and MV; Both groups had almost full recovery of lung function; MV patients reported more fatigue, weakness, and limitation in daily activities; VV-ECMO survivors had higher HRQoL scores and lower PTSD rates than non-ECMO survivors | Mean VV-ECMO SF-36 scores were significantly lower compared to matched healthy controls for all domains except bodily pain and role-emotional; 42% of survivors were unable to perform usual activities and described severe or extreme anxiety and depression; 80% of survivors had no problem with personal care; 52% returned to work and 29% returned to previous work level at the follow-up time | Significantly lower mean SF-36 of physical functioning and physical component scores for VV-ECMO survivors. No statistical difference was found in the SF-36 scores between VV-ECMO survivors and matched general population in Ireland for the following domains: mental health, social function, vitality, and a mental component. Results from the HADS questionnaire showed that seven participants (54%) of VV-ECMO survivors experienced anxiety of which five of whom (38.5%) suffered from severe anxiety. Two participants (15%) showed a HADS-D score of ≥ 8, which is associated with depression. Three participants (23%) were considered to be at risk for PTSD. Four of the six (67%) of participants had returned to work at the follow-up time | No significant differences were found between VV-ECMO and MV for EQ-5D, SF-36, St George’s hospital respiratory questionnaire, hospital anxiety and depression scale, and mini-mental state examination | Physical role limitations and general-health perceptions were the worst SF-36 domains (25 and 56, respectively). Psychological tests showed high risk of depression (39–42%, patients; 39–52%, caregivers), anxiety (42% patients; 39% caregivers), and PTSD (47% patients; 61% caregivers). Patients depression or anxiety scores were correlated to age and the outcome reported by caregivers | Lower cognitive function was experienced by 55% of ECMO and 56% of MV survivors. ECMO and MV survivors had similar depressive symptoms (36% vs 39%, respectively), as well as anxiety symptoms (55% vs 44%, respectively) and PTSD (33% vs 44%, respectively). At the follow-up time, 46% of VV-ECMO had returned to their original work as compared to 67% of MV survivors | No statistically differences were found in EQ-between VV-ECMO and MV scores; 13% VV-ECMO and 15% MV reported fatigue and decreased endurance; 42% VV-ECMO and 27% MV reported symptoms of anxiety or depression; 67% VV-ECMO and 50% MV survivors returned to work |
HRQoL of the studies
HRQoL evaluation tools
HRQoL results of ARDS patients following VV-ECMO
HRQoL of ARDS patients treated with VV-ECMO vs. conventional ventilatory support
Risk of bias within studies
Galazzi et al. [39] | Grasselli et al. [40] | Hodgson et al. [41] | O’Brien et al. [42] | Sanfilippo et al. [44] | Sylvestre et al. [45] | Wang et al. [46] | |
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1. Was the research question or objective in this paper clearly stated? | Y | Y | Y | Y | Y | Y | Y |
2. Was the study population clearly specified and defined? | Y | Y | Y | N | Y | Y | Y |
3. Was the participation rate of eligible persons at least 50%? | Y | Y | Y | Y | Y | N | Y |
4. Were all the subjects selected or recruited from the same or similar populations (including the same time period)? | Y | Y | Y | Y | Y | Y | Y |
Were inclusion and exclusion criteria for being in the study prespecified and applied uniformly to all participants? | Y | Y | Y | Y | Y | Y | Y |
5. Was a sample size justification, power description, or variance and effect estimates provided? | N | N | N | N | N | N | N |
6. For the analyses in this paper, were the exposure(s) of interest measured prior to the outcome(s) being measured? | N | Y | N | Y | Y | Y | Y |
7. Was the timeframe sufficient so that one could reasonably expect to see an association between exposure and outcome if it existed? | Y | Y | Y | Y | Y | Y | Y |
8. For exposures that can vary in amount or level, did the study examine different levels of the exposure as related to the outcome (e.g., categories of exposure, or exposure measured as continuous variable)? | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
9. Were the exposure measures (independent variables) clearly defined, valid, reliable, and implemented consistently across all study participants? | Y | Y | Y | Y | Y | Y | Y |
10. Was the exposure(s) assessed more than once over time? | N | N | N | N | N | N | N |
11. Were the outcome measures (dependent variables) clearly defined, valid, reliable, and implemented consistently across all study participants? | Y | Y | Y | Y | Y | Y | Y |
12. Were the outcome assessors blinded to the exposure status of participants? | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
13. Was loss to follow-up after baseline 20% or less? | Y | Y | Y | Y | Y | Y | Y |
14. Were key potential confounding variables measured and adjusted statistically for their impact on the relationship between exposure(s) and outcome(s)? | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
Domain | Source of bias | Support for judgement | Review authors’ judgement |
---|---|---|---|
Selection bias | Random sequence generation | “Patients were enrolled from three types of centres: the ECMO centre at Glenfield Hospital, Leicester, which treated all patients who were randomly allocated for consideration to receive ECMO; tertiary intensive care units (conventional treatment centres); and referral hospitals, which sent patients to the conventional treatment centres if they were randomly allocated to receive continued conventional management.” | Low risk |
Allocation concealment | “Patients were randomly allocated by minimisation in a 1:1 ratio to conventional management by intermittent positive-pressure ventilation or high-frequency oscillatory ventilation, or both, or consideration for treatment by ECMO. Minimisation factors were type of centre; age; hours of high-pressure or high FiO2 ventilation; presence of hypoxia or hypercarbia; diagnostic group; and number of organs failed.” | High risk | |
Performance bias | Blinding of participants and personnel | Blinding of participants and personnel was not described | Unclear risk |
Blinding of outcome assessment | Blinding of outcome assessment was not described | Unclear risk | |
Attrition bias | Incomplete outcome data | “Consequently, the number of patients with missing data are lower than for other components of EQ-5D, and other follow-up and economic assessments.” | High risk |
Reporting bias | Selective reporting | The primary and secondary outcomes are identifiable in the published report | Low risk |
Other bias | Other source bias | None were identified | Low risk |